Empagliflozin 25 mg tablet (Enpyangjeong)

Adult dose

The recommended dosage is 10 mg once daily for monotherapy and in combination therapy with insulin or other hypoglycemic agents. If the tolerance is good and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medication can be taken regardless of meals; swallow the tablet whole. If you forget to take a dose, take it as soon as you remember, but do not take two doses on the same day.

This medication should not be used in certain patients. First, patients with allergic reactions to the active ingredient or any of the components should not take this drug. Second, this drug is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. Third, it should not be administered to patients with significantly impaired kidney function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m² or patients with end-stage renal disease or those on dialysis. Fourth, this drug contains lactose; hence, patients with lactose intolerance, galactose intolerance, or hereditary lactose enzyme deficiency must not use it. Furthermore, it should be used with caution in patients with somewhat impaired kidney function, and it is advisable not to initiate treatment if the glomerular filtration rate is below 60 mL/min/1.73m². If the glomerular filtration rate falls below 45 mL/min/1.73m² during treatment, the administration should be stopped. In patients with end-stage renal disease or those on dialysis, the efficacy of this medication is not expected, so it should not be used. In patients with heart failure, it should be administered with caution in NYHA class I-II, and it is not recommended for those in class III-IV. There is an increased risk of hypoglycemia when used with insulin or sulfonylureas, so in such cases, it may be necessary to adjust the dosage of insulin or sulfonylureas. Possible adverse reactions that may occur while using this medication include hypoglycemia, genital infections (vulvovaginitis, vulvar inflammation, glans inflammation, etc.), increased urination, urinary tract infections, decreased fluid volume, etc. Particularly, hypoglycemia may occur more frequently when combined with insulin or sulfonylureas, so caution should be exercised. Also, blood tests may temporarily show an increase in serum creatinine or a decrease in glomerular filtration rate, but these usually resolve after discontinuing treatment. Rarely, a serious metabolic abnormality known as ketoacidosis may occur; therefore, if symptoms such as vomiting, abdominal pain, or breathing difficulties arise, immediate consultation with a physician is necessary. This medication is not recommended for pregnant women, and if pregnancy is confirmed, it should be discontinued. While breastfeeding, it is also advisable to avoid using this medication and to discontinue breastfeeding during treatment. This medication has not been shown to be safe and effective in children under 18 years of age and should not be used in this population. No specific toxic symptoms have been reported in case of overdose, but appropriate treatment according to the patient's condition is necessary in the event of excessive intake. Finally, this medication should be stored out of reach of children, and care should be taken not to transfer it to other containers as this may affect quality.

Serious side effects

Hives, severe swelling (angioedema), ketoacidosis, perineal necrosis, urinary sepsis, pyelonephritis, acute renal injury, severe skin reactions (severe rash, blistering, peeling of the skin, pain in oral/ocular mucosa), liver abnormalities (jaundice of the skin or eyes, generalized malaise), serious neurological symptoms (headache, stroke, intracranial aneurysm, confusion, paralysis), heart failure (not recommended in NYHA class III-IV),

Mild side effects

• Hypoglycemia
• vulvovaginitis
• vulvar inflammation
• glans inflammation
• and other genital infections
• increased urination
• increased serum lipids
• increased serum creatinine
• decreased glomerular filtration rate
• thirst

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, preferably at room temperature between 1°C and 30°C. Avoid direct sunlight and high temperatures, and keep it out of the reach of children.

Appearance

Pale yellow, biconvex, oval film-coated tablet

Package unit

30 tablets/bottle